Focal cryoballoon ablation is an effective and safe treatment modality for patients with dysplastic Barrett's esophagus.
ID
Bron
Verkorte titel
Aandoening
Barrett's esophagus
Barrett slokdarm
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Efficacy, defined as:<br>
- CE-IM; the percentage of patients with complete eradication of all Barrett’s epithelium on endoscopy AND CE-IM in all biopsies obtained at the first follow-up endoscopy after the maximum of 5 treatment sessions (and escape treatment(s) if necessary).<br>
- CE-D; the percentage of patients with CE-D in all biopsies obtained at the first follow-up endoscopy after the maximum of 5 treatment sessions (and escape treatment(s) if necessary).
Achtergrond van het onderzoek
Evaluation of the efficacy and safety of the C2 Cryoballoon Focal Ablation system.
Doel van het onderzoek
Focal cryoballoon ablation is an effective and safe treatment modality for patients with dysplastic Barrett's esophagus.
Onderzoeksopzet
Baseline (first treatment endoscopy), follow-up endoscopies at a 3 month interval, last treatment endoscopy.
Onderzoeksproduct en/of interventie
CryoBalloon™ Focal Ablation System (CbFAS)
Publiek
Anouk Overwater
St. Antonius Ziekenhuis/UMCU
[default]
The Netherlands
0031887550224
a.overwater@umcutrecht.nl
Wetenschappelijk
Anouk Overwater
St. Antonius Ziekenhuis/UMCU
[default]
The Netherlands
0031887550224
a.overwater@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Indicated for ablation therapy of Barrett’s epithelium, determined by:
o Histopathologically-confirmed LGD or HGD in flat-type BE with four quadrant biopsies of every 2cm of the BE segment in the last 6 months, or
o Residual flat BE (with or without dysplasia) after endoscopic resection of a focal lesion (by means of EMR or ESD) of non-flat BE, at least 6 weeks prior to enrolling the patient to this study. The histopathologic evaluation of the resected specimen should indicate endoscopic treatment (i.e., no more than only superficial submucosal invasion (≤T1sm1/<500 microns), absence of lymphovascular invasion, not poorly differentiated, free deep (vertical) resection margins).
NB: In case of performed endoscopic resection, the absence of residual cancer in the remaining Barrett’s epithelium should be confirmed with random biopsies (these biopsies might be taken during the same endoscopy, but a maximum interval of 6 months is allowed between these biopsies and study inclusion).
- Ablation naïve (no previous ablation therapy of the esophagus)
- Prague Classification ≤C2 / ≤M5 (including BE tongues, excluding small BE islands, in case of endoscopic resection Prague Classification AFTER endoscopic resection)
- Older than 18 years of age at time of consent
- Operable per institution’s standards
- Informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Esophageal stenosis preventing advancement of a therapeutic endoscope
- Prior endoscopic resection (EMR or ESD) >2cm in length AND/OR >50% of the esophageal circumference
- Prior distal oesophagectomy
- Active oesophagitis grade B or higher (patients can be included after appropriate treatment of reflux oesophagitis)
- History of oesophageal varices
- Achalasia
- Severe medical comorbidities precluding endoscopy
- Uncontrolled coagulopathy
- Pregnant or planning to become pregnant during period of study participation
- Life expectancy ≤2 years, as judged by the site investigator
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7253 |
| NTR-old | NTR7460 |
| CCMO | NL64555.100.18 |
| OMON | NL-OMON50590 |